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Wysa Ltd.’s artificial intelligence-based digital therapy received FDA breakthrough device designation for adults with chronic musculoskeletal pain, depression and anxiety. The device delivers cognitive behavioral therapy (CBT) via a digital companion or conversational agent on a smartphone.
As the American Urological Association (AUA) annual meeting prepares to kick off on May 12, newly published prostate cancer guidelines recommend two tests to help clinicians and patients determine the best path forward for treatment—or waiting. The latest AUA guidelines incorporated Exact Sciences Corp.’s Oncotype DX Genomic Prostate Score (GPS) test for risk-stratification of localized prostate cancer, while the National Comprehensive Cancer Network (NCCN) added Cleveland Diagnostics Inc.’s Isopsa test to help identify high-grade early prostate cancer before a biopsy or after a negative biopsy result.
The short-term future is a little clearer for Israeli precision oncology startup Oncohost Ltd. now that it has closed a $35 million series C fundraising round. The new infusion more than doubled the previous amount raised, bringing total investment to more than $50 million. The company plans to use the funds to expand its PROPHETIC trial of the company’s machine learning-based host response profiling platform, Prophet, to additional locations worldwide and new indications.
Cvrx Inc. secured U.S. FDA approval for magnetic resonance-conditional labeling for its Barostim system, a neuromodulator that improves symptoms of patients with heart failure. With the latest approval, patients with the implanted system can have magnetic resonance imaging (MRI) at 1.5T under the specified conditions.
Sidekick Health AB stepped into a leading role in the fast-growing digital health space with the closing of a $55 million series B this week and an ever larger number of partners for its gamified app. Designed to help better manage multiple chronic conditions, the digital therapeutic engages users in video game-like activities and rewards positive changes in lifestyle choices while delivering personalized educational components.
Mark it as a day to remember. The U.S. FDA has awarded de novo marketing authorization for the first in vitro diagnostic (IVD) test for Alzheimer’s disease (AD), enabling diagnosis of the dreaded disease years earlier than current clinical tests. Fujirebio Diagnostics Inc.’s Lumipulse G β-Amyloid Ratio (1-42/1-40) measures specific proteins in cerebral spinal fluid to provide rapid assessment of the risk of amyloid plaques, an indicator of the disease that may develop decades before cognitive impairment occurs.
Mark it as a day to remember. Today the FDA authorized the first in vitro diagnostic test for Alzheimer’s disease, enabling diagnosis of the dreaded disease years earlier than current clinical tests. Fujirebio Diagnostics Inc.’s Lumipulse G β-Amyloid Ratio (1-42/1-40) measures specific proteins in cerebral spinal fluid to provide rapid assessment of the risk of amyloid plaques, an indicator of the disease that may develop decades before cognitive impairment occurs.
Orthofix Medical Inc. continues to expand its bone growth product line with a new premarket approval from the FDA for its Accelstim bone healing therapy device. Indicated for certain fresh fractures and fractures that have not healed, the device uses low-intensity pulsed ultrasound to stimulate the natural healing process. The company plans to take a phased approach to the launch, which will begin within weeks.
Isono Health Inc. received FDA clearance for its Automated Three-dimensional Ultrasound with Artificial intelligence (ATUSA) system for breast imaging, a wearable, compact automated whole breast ultrasound system that can acquire high-quality images without requiring a skilled operator. The ultrasound scan takes two minutes to scan the entire breast volume and offers 3D visualization of the breast tissue.
Four months after debuting W1 health watch at Arab Health 2022, Masimo Corp. reported a limited release of the consumer version of the device in the U.S. to 10,000 users on a first come-first served basis. The wrist-worn device, which measures oxygen saturation, pulse rate, perfusion index, pleth variability index and respiration rate, also counts steps and detects falls.
